Application 079198
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | No | No |
| 002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML | No | No |
| 003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-239 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-245 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |
| 67457-246 | Octreotide Acetate | octreotide acetate | Mylan Institutional LLC | ANDA | Current |